MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT

Model Number	H7493941812220
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 20% stenosed target lesion was located in the severely tortuous and non-calcified circumflex artery.A 2.25 x 12mm synergy xd drug-eluting stent was advanced for treatment but failed to cross recently deployed proximal stent.The physician pushed and pushed until the hypotube of the delivery system fractured.All of the device components were removed without issue.The physician elected to stop the procedure after fracture and end the case.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.25 x 12mm mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed via scope, and no issues were noted.The balloon wings were tightly wrapped and evenly folded.The balloon had not been subjected to positive pressure.A visual and microscopic examination of the bumper tip showed signs of distal tip damage.A visual and tactile examination of the hypotube identified a break on the hypotube shaft located at 18.3 cm distal to the distal end of strain relief as well as multiple kinks.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.No issues were noted.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.The 20% stenosed target lesion was located in the severely tortuous and non-calcified circumflex artery.A 2.25 x 12mm synergy xd drug-eluting stent was advanced for treatment but failed to cross recently deployed proximal stent.The physician pushed and pushed until the hypotube of the delivery system fractured.All of the device components were removed without issue.The physician elected to stop the procedure after fracture and end the case.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12356910
• Report Number: 2134265-2021-10594
• Device Sequence Number: 4535840
• Product Code: NIQ
• UDI-Device Identifier: 08714729980711
• UDI-Public: 08714729980711
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: H7493941812220
• Device Lot Number: 0027193788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1